TMS + Exposure Therapy for Pediatric OCD
NExT
Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD
1 other identifier
interventional
50
1 country
2
Brief Summary
The goal of this clinical trial is to compare different forms of transcranial magnetic stimulation (TMS) for improving the outcomes of Exposure with Response Prevention (ERP) in youth and young adults with Obsessive-Compulsive Disorder (OCD). Researchers will compare three groups: ERP with one of two different active ("real") forms of TMS vs. ERP with sham ("fake") TMS. The main questions this study aims to answer are: 1) whether TMS normalizes functioning in brain circuits that contribute to compulsive behavior, and 2) whether TMS reduces compulsions during ERP. Participants will:
- Complete clinical interviews, questionnaires, and computerized tasks
- Complete two MRIs (brain scans)
- Receive daily TMS followed by ERP for two weeks (10 sessions)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2023
CompletedFirst Posted
Study publicly available on registry
July 5, 2023
CompletedStudy Start
First participant enrolled
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
April 8, 2026
April 1, 2026
2.3 years
June 15, 2023
April 2, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit
z-score representing change in resting state connectivity between presupplementary motor area (pSMA) and dorsolateral striatum (DLS)
change from baseline at two weeks (post-treatment)
Functional Magnetic Resonance Imaging (fMRI): connectivity of the dlPFC-DMS circuit
z-score representing change in resting connectivity between dorsolateral prefrontal cortex and dorsomedial striatum (DMS)
change from baseline at two weeks
Observed Compulsive Behavior
Mean proportion of time during which compulsions are observed during ERP sessions
two weeks
Secondary Outcomes (1)
Child/Adult Yale-Brown Obsessive Compulsive Inventory
change from baseline at two weeks (post-treatment)
Study Arms (3)
ERP+iTBS
EXPERIMENTALParticipants will receive two weeks (10 sessions) of intermittent theta burst stimulation (iTBS; a form of TMS) targeting the dorsolateral prefrontal cortex (dlPFC), followed immediately by Exposure Plus Response Prevention (ERP).
ERP+cTBS
EXPERIMENTALParticipants will receive two weeks (10 sessions) of continuous theta burst stimulation (cTBS; a form of TMS) targeting the presupplementary motor area (pSMA), followed immediately by Exposure Plus Response Prevention (ERP).
ERP+Sham
ACTIVE COMPARATORParticipants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP).
Interventions
ERP will be delivered daily, immediately following TMS
Sham stimulation will use the Magstim sham air-cooled coil, which produces auditory signals and appears identical to an active coil but contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (\<3%) magnetic field is delivered to the cortex
TMS will be delivered over the pre supplementary motor area (preSMA) using a continuous bursting pattern
TMS will be delivered over the dorsolateral prefrontal cortex (dlPFC) using an intermittent bursting pattern
Eligibility Criteria
You may qualify if:
- Between the ages of 12 and 21 years.
- Presence of OCD, as indicated by a score of \> 16 on the Children's Yale-Brown Obsessive Compulsive Scale, indicating moderate or greater OCD symptoms.
- Presence of motor compulsions on CY-BOCS compulsion checklist
- English fluency to ensure comprehension of informed consent and study measures and instructions.
You may not qualify if:
- Decline to provide informed consent.
- Has a personal history, or a family history in a first-born relative, of any medical or psychiatric disorder, disease, condition, injury, symptoms or circumstance that, in the opinion of the principal investigator, may: (1) impact the risk profile of TMS; (2) reduce the subject's ability to fulfill the study requirements as per protocol; or (3) adversely impact the integrity of the data or the validity of the study results." Some examples include: epilepsy or seizure disorder(s), bipolar disorder or any psychiatric disorder associated with a risk of mania, intracranial pathology, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, or moderate-severe heart disease
- Pregnant according to the medical history or a urine pregnancy test; and menstruating females who are heterosexually active and not using a highly effective form of contraception (tubal ligation, FDA-approved hormonal contraceptive, or an IUD)
- Inability to undergo MRI.
- Left handedness.
- Is deemed to be at imminent risk of suicide according to the Ask Suicide-Screening Questions (ASQ) (i.e. answers YES to ≥ one (1) of the four screening questions) and/or in the medical opinion of the investigator
- History of, or risk factors for, neurocardiogenic syncope (history of syncope/ presyncope related to noxious stimuli, anxiety, micturation, or posture).
- Concurrent psychotherapy of any kind for OCD.
- Concurrent TMS or receipt of any TMS experimental or clinical treatment less than 3 months prior to enrollment.
- Taking a medication deemed to pose high seizurogenic potential per physician review
- Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the study period)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bradley Hospitallead
- University of Minnesotacollaborator
- Butler Hospitalcollaborator
Study Sites (2)
University of Minnesota
Minneapolis, Minnesota, 55414, United States
Emma Pendleton Bradley Hospital
Riverside, Rhode Island, 02915, United States
Related Publications (1)
Conelea C, Breitenfeldt C, Wilens A, Carpenter L, Greenberg B, Herren J, Jacob S, Lewis C, McLaughlin N, Mueller BA, Nelson S, O'Connor E, Righi G, Widge AS, Fiecas M, Benito K. The NExT trial: Protocol for a two-phase randomized controlled trial testing transcranial magnetic stimulation to augment exposure therapy for youth with OCD. Trials. 2024 Dec 18;25(1):835. doi: 10.1186/s13063-024-08629-1.
PMID: 39696590DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristen Benito, PhD
Emma Pendleton Bradley Hospital
- PRINCIPAL INVESTIGATOR
Christine Conelea, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants, parents (if applicable), the ERP therapist, the independent evaluator (but not active vs. sham status).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor (Research)
Study Record Dates
First Submitted
June 15, 2023
First Posted
July 5, 2023
Study Start
March 20, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- We will upload raw data twice yearly and all other data at the time of publication or end of the project. The research community will have access to all de-identifiable data when the award ends. NDA will make decisions about how long to preserve the data. We will share the study protocol and consent form after obtaining IRB approval.
- Access Criteria
- Data can be accessed through the NDA by investigators working under an institution with a Federal Wide Assurance (FWA)
We will share all de-identifiable data from study measures through the National Institute of Mental Health (NIMH) Data Archive (NDA) using the data dictionaries available in NDA. As per NIMH Data Archive, data will be deidentified and assigned a Global Unique Identifier (GUID). We will also share deidentified study data via the National Database for Clinical Trials (NDCT) related to Mental Illness.